Adverse Drug Reactions
Those involved with medication therapy, especially for the elderly, are aware of the “medication system nightmare” that results from the complexity of medications, the number of physicians prescribing for the same patient, the trial and error nature of prescribing, and the palpable negative impact that this has on both quality of care and total costs. For instance, the number one reason for hospital recidivism is medication related (i.e., hospital readmissions of the elderly within 30 days of discharge, for the same problem they had on the first admission). There is no standard system to reconcile medications for these discharge patients. In the absence of a reconciliation, patients are often discharged with new medications from a hospital or skilled nursing facility and left to return home to find existing prescriptions in their home, often from unrelated specialists that may or may not be necessary or even safe to consume in light of the patient's new medical regimen.
One futile attempt at solving this problem has been to require home health agency nurses to perform the reconciliation task. Often, nurses profess that their medication knowledge is scant and they feel frustrated attempting to do this task. There are few community primary care physicians remaining, and even those who are in practice rarely can see a patient within a few days from hospital discharge to work through this medication reconciliation issue. Furthermore, the community primary care practitioners do not receive a timely report about the hospitalization, nor are they any longer involved with such care in many instances. Hospitalists, employed by the hospital, provide care and perform discharge summaries, but do not focus on medication reconciliation.
Over the past few years, data has emerged indicating that, nationwide, between 19.6% and 25% of Medicare patients discharged from U.S. hospitals are readmitted within 30 days for the same diagnosis, costing the government between $19 billion and (with some estimates as high as) $100 billion. Of these amounts, some 75% is deemed to be preventable. One large payer in Philadelphia has already stopped paying for readmissions for the same diagnosis within 14 days of discharge. Literature is replete with data indicating that a Nurse Practitioner home visit within days of discharge, in addition to pharmacist-led medication reconciliation, is cardinal to avoiding rehospitalizations.
While most hospitalizations are necessary and appropriate, in early 2009, the New England Journal of Medicine reported that nearly one in every five elderly patients who are discharged from the hospital are rehospitalized within 30 days. Jencks S F, Williams M V, Coleman E A. Rehospitalizations among patients in the Medicare fee-for service program. New England Journal of Medicine. 2009, 360(14):1418-1428.
In fact, 50% of patients who were rehospitalized within thirty days had no intervening primary care visit between discharge and rehospitalization. This area of high cost and low quality has been, and continues to be, a target of payment reform. Boutwell, A. Jencks, S. Nielsen, G A. Rutherford, P. State Action on Avoidable Rehospitalizations (STARR) Initiative: Applying early evidence and experience in front-line process improvements to develop a state-based strategy. Cambridge, Mass.: Institute for Healthcare Improvement; 2009.
In 2007, MedPac analysis estimated that as many as 17.6% of medicare rehospitalizations were avoidable through establishing a stable and safe transition of care from the hospital to the home. In addition, savings from preventing readmissions can be considerable. According to the Apr. 21, 2009, Medicare Payment Advisory Commission report to the Senate Finance Committee on Reforming America's Health Care Delivery System, 18% of Medicare hospital admissions resulted in readmissions with 30 days of discharge, accounting for $15 billion in spending and that Medicare spends about $12 billion on potentially preventable readmissions.
Aside from the problems with rehospitalization, over 2 million serious Adverse Drug Reactions (ADRs) are reported annually, accounting for 100,000 annual deaths in the United States. ADRs are the cause for 6% to 7% of all hospitalizations and an increase of an average of 2 days for the average length-of-stay in a hospital. ADRs are the fourth leading cause of death in the United States, amounting to more deaths than those resulting from pulmonary diseases, diabetes, AIDS, pneumonia, accidents and automobile deaths combined.
Senior citizens bear the brunt of the ADR problems because 40% of seniors take five or more medications per week. Up to 12% of seniors take ten or more medications per week. While the incidents of drug metabolizing interactions is 13% for two medications, it climbs to 82% for seven or more simultaneous medications. A system relying on in-house clinicians and pharmacists miss or ignore potential dangerous drug interactions up to half of the time. Furthermore, the new discipline of pharmacogenomics, discussed below, is rarely utilized, based on a lack of familiarity with this new discipline.
Pharmacogenomics
Pharmacogenomics is an emerging personalized medicine discipline. Pharmacogenomics is the science concerned with ways to compensate for genetic differences in patients which cause varied responses to a single drug. http:www.merriam-ebster.com/dictionary/pharmacogenomic (last accessed, Oct. 25, 2011). Pharmacogenomic data may be used by health care professionals to: (1) determine which patients will require specific treatments, (2) predict which patients will respond to therapy, (3) predict the right dose for the right patient, and (4) predict which patients will have an adverse reaction to selected therapies. Tanzi M G, Posey L M. Pharmacogenomics takes San Antonio by storm. Pharmacy Today. 2009; 15(6):27-30. For over a decade, pharmacogenomic-based technology and its integration into clinical practice have been the focus of scientists, industries and practitioners.
Pharmacogenomic-related information is contained in about ten percent of labels for drugs currently approved by the Food and Drug Administration (“FDA”). A significant increase of labels containing such information has been observed over the last decade.
www.fda.gov/Drugs/ScienceResearch/ResearchAreas/pharmacogenetics/ucm083378.htm (last accessed, Oct. 25, 2011). It is believed that there are approximately 225 genes that determine the integrity of more than 1,800 drug metabolizing enzymes.
Specific genetic variations are associated with more than 1,500 health conditions, including Alzheimer's disease, inherited breast and ovarian cancer, cystic fibrosis, hemophilia, Huntington's disease and myotonic dystrophy. These genetic risk assessments however do not guarantee that individuals will or will not develop a condition. Pharmacogenomics, on the other hand, is much more refined—enabling high probability predictions on whether a medication will work for a particular patient, and how much of it will be effective.
In order to perform a pharmacogenomics DNA test, cell samples are obtained with a cheek swab. It is not necessary to sequence an individual's entire genome in order to examine specific pharmacogenomic genotypes. Pharmacogenomic diagnostic tests identify select genetic variations, also referred to as single nucleotide polymorphisms (SNPs), within the human genome. See, http://www.ncbi.nlm.nih.gov/genome/guide/human (last accessed on Oct. 25, 2011). A central repository for single base nucleotide substitutions and short deletion and insertion polymorphisms is supported by the National Center for Biotechnology Information (NCBI) and the National Human Genome Research Institute (NHGRI). Tanzi M G, Posey L M. Pharmacogenomics takes San Antonio by storm. Pharmacy Today. 2009; 15(6):27-30.
Pharmacogenomics forms the platform for the practice of personalized medicine. Personalized medicine is the use of a person's clinical, genetic, genomic and environmental information to select a medication, its dose, choose a therapy or recommend preventative health measures. The goal of personalized medicine is to optimize health care and medical outcomes by utilizing a preventative, coordinated and evidence-based approach. Personalized medicine does not refer to the creation of drugs designed for an individual, but rather for the subpopulations of patients that differ in their susceptibility to a particular disease or their response to a specific treatment. President's Council of Advisors on Science and Technology. Priorities for Personalized Medicine. 2008.
The promise of personalized medicine, for which evidence already exists, includes the ability to: (i) shift emphasis in medicine from reaction to prevention; (ii) enable the selection of optimal therapy and reduce trial and error prescribing; (iii) make the use of drugs safer by avoiding adverse drug reactions; (iv) increase patient compliance with treatment due to fewer side effects; (v) reduce the time and cost of clinical trials; (vi) revive drugs that are failing in clinical trials or were withdrawn from the market; and (vii) reduce the overall cost of healthcare.
In a 2006 study, it was estimated that proper genetic testing and dosing of warfarin may have prevented 17,000 strokes, 85,000 serious bleeding events and 43,000 visits to the emergency department. Subtracting the price of two million genetic tests costing between $125 and $500 per patient, an overall savings to the helath care system would have been approximately $1.1 billion. McWilliam A., Lutter R., Nardinelli C., Health Care Savings from Personalized Medicine Using Genetic Testing: the case of warfarin. AEI-Brookings Joint Center. 2006. Available at, http://aei-brookings.org/admin/authorpdfs/redirect-safety.php?fname=./pdffiles/WP06-23 topost.pdf.
Current practicing prescribers understand the immense value of pharmacogenomics, but have not been trained in translating it into application. An October 2008 study by MEDCO, with responses from 10,303 prescribing physicians, indicated that while 98% of physicians agree that patient genetic profiles will influence prescribing, less than 10% believe they are adequately informed (educated) about applying pharmacogenomics. See, https://www.medcoresearch.com/community/pharmacogenomics/physicia nsurvey. (last accessed, Jan. 10, 2010).
A report by the National Institute of Health's (“NIH”) Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) recognizes the current challenges of integrating pharmacogenomics into clinical practice as: (i) product development and clinical studies must be adapted to assess the accuracy and predictive value of pharmacogenomic-based diagnostics; (ii) clinical trials must be adapted to determine the safety, efficacy, and effectiveness of pharmacogenomic-based therapies; (iii) regulation of pharmacogenomic-related products that foster innovation while ensuring patient safety and improved outcomes; (iv) coverage and reimbursement of pharmacogenomic technologies may be insufficient to support the development and manufacturing costs of these therapies and tests; (v) health information technology infrastructure must be sufficiently robust, detailed and interoperable to support research, treatment decisions and surveillance; (vi) education and training for physicians and other clinicians are essential to ensure that their competence with pharmacogenomic technologies and their ability to counsel patients and families to make informed health care decisions; and (vii) ethical, legal and societal issues will continue to arise as advances in pharmacogenomics result in greater compilation, transmission and use of genetic information. Realizing the potential of Pharmacogenomics: Opportunities and Challenges. Secretary's Advisory Committee on Genetics, Health, and Society. May 2008. Available at, http://oba.od.nih.gov/oba/SACGHS/reports/SACGHS PGx report.pdf (last accessed, Oct. 25, 2011).
Others have attempted to solve related problems in the art. For example, U.S. Patent Pub. No. 20110000170 describes a process where prescriptions are sent to a database to produce a regimen care schedule that results in a medicine pack being created pursuant to the schedule. Each medical card has a week's worth of medicine to be administered at various times of day. The program also determines if prescriptions would create interactions based on, for example, patient allergies.
U.S. Patent Pub. No. 20070173971 utilizes a database to collect information from a pharmacy or a patient and ultimately dispenses the medication in pouches.
U.S. Patent Pub. No. 20110166877 discloses quality control methods for a medication therapy management system. The application discloses a process for developing clinical rules by seeking consensus among practitioners and then translating those rules into computer code that triggers PharmD intervention.
U.S. Patent Pub. No. 20090265189 discloses a system that receives input from pharmacy claims, lab data, medication risk assessment data and other sources. After rules are established, the existing data is screened to identify any medication risks. Patient-specific follow-up is then suggested.
U.S. Patent Pub. No. 20090254371 discloses the development of clinical rules based on national standards and a peer review process
U.S. Patent Pub. No. 20080126131 discloses medication therapy management. The problem of drug-drug, drug-disease, drug-age and patient-genetic interactions ([0004] and [0030]) are discussed. Similar matter is addressed in U.S. Patent Pub. No. 20080126117.
Despite these advances, there still exists a need in the art for a centralized system that would permit health care providers, pharmacists, patients and patient caregivers to have coordinated access to all of the same information to prevent miscommunication or misunderstanding, particularly during transitions from health care facilities to the home. A further need exists in the art for the centralized system to validate that a patient's entire drug regimen is safe and effective in light of potential adverse health consequences for drug interactions and potential adverse health consequences based on a particular drug in light of a patient's personal gene interactions with the drug or a patient's clinical laboratory results.